CN106138126A - The preparation method of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces - Google Patents
The preparation method of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
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Abstract
The present invention provides the preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces, by using medical material through picking cleaning/process of preparing Chinese medicine, it is dried, broken, the pulverizer of 100 mesh sieves is pulverized, batch (-type) sterilizes, breaking cellular wall, pelletize, it is dried and prepares Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces, the particle type of the decoction pieces of preparation is preferable, elasticity is moderate, and the granule prepared is easier to be dried, granule leaches comparatively fast, Extracting ratio is high, it is easily dispersed when user is taken, the decoction pieces that batch (-type) sterilization is meets the requirement of microbial limit, solve Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces in the market and leach the difficult and difficult problem up to standard of microbial limit.
Description
Technical field
The present invention relates to Chinese medicine processing technology field, particularly belong to the preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces.
Background technology
Superfine communication technique is the new technique developed rapidly in recent years.Effective ingredient in Chinese crude drug is distributed in mostly
Intracellular, conventional decoction pieces can only make part effective ingredient discharge when decocting, utilization rate of active components 10-30%；And use
Wall breaking pulverization technology, as being crushed to about 300 mesh by the prepared slices of Chinese crude drugs, cell-wall breaking ratio is up to 86.7%, improves in medical material
The dissolution of effective ingredient, is greatly enhanced its drug effect, and utilization rate of active components, more than 90%, reaches to reduce medical material usage amount and guarantor
Protecting herb resource, the quality that the most also can improve medicine increases drug effect.Balanophora dioica R Br ex Royle, is Balanophoraceae Balanophora plant, and Balanophora dioica R Br ex Royle is complete
Strain cerise, to kermesinus, turns aubergine sometimes；Rhizome branch, subsphaeroidal, surface is close by coarse fleck with yellowish white star
Aristiform hole skin.Scape squama bract ellipticity Long Circle, tip is blunt, alternate, and base portion is several encloses scape entirely.People use it as medicine
Material, is all that herb Processing methods forms.Balanophora dioica R Br ex Royle have the liver and the kidney tonifying, hemostasia and promoting granulation, regulating menstruation and activating blood, heat clearing away relieving alcoholic intoxication, regulate the flow of vital energy strong
Stomach, effect of heat-clearing and toxic substances removing, for impotence and seminal emission, edema, menorrhagia, leukorrhagia, neurosis, chronic hepatitis, peratodynia,
Digestive tract hemorrhage, wind heat macule, cough due to lung-heat, traumatic hemorrhage etc..
Open a kind of Balanophora dioica R Br ex Royle ultramicro pure powder of CN201310212681.3 and preparation method thereof and preparation, described Balanophora dioica R Br ex Royle
Ultramicro pure powder is with fresh Balanophora dioica R Br ex Royle as raw material, through pre-treatment, be dried, coarse pulverization, micronizing, subpackage sterilization steps system
?.The preparation method of described Balanophora dioica R Br ex Royle ultramicro pure powder include pre-treatment, be dried, coarse pulverization, micronizing, subpackage sterilizing step
Suddenly, specifically include: foreign material in Balanophora dioica R Br ex Royle are rejected, through cleaning, clean, dry, dry, pulverize 10 mesh sieves；The material pulverized
Carry out micronizing respectively and i.e. obtain object；Subpackage sterilizing, inspection, provide report.
CN200610122171.7 discloses the processing method of a kind of traditional Chinese herbs broken wall powder, and the step of its processing is: (1) medical material
Concoct: it includes selection, section, dried clean medical material；(2) pulverize: with above-mentioned clean medical material, with the omnipotent powder of 100 mesh sieves
Broken machine is pulverized, and wall breaking pulverization obtains the 60 above coarse powder of mesh；(3) wall breaking pulverization: by coarse powder flour obtained as above, through wall cell disruption powder powder
It is broken to more than 300 mesh, obtains superfine powder；(4) pelletize: take superfine powder obtained as above, put in flute profile mixing and blending machine, use water
Or ethanol makes soft material, pelletizing through the oscillating granulator of 30 mesh sieves, the wet granular prepared is put in heated-air circulation oven and is dried；
(5) granulate, screening: with upper strata 40 mesh, above-mentioned granulation granulate is sieved 1-3 time, makes 40 by the vibration pelletizing machine of lower floor 80 mesh sieve
Granule between mesh-80 mesh；(6) subpackage and packaging: take qualified sub-micron-powder, subpackage and outer package and obtain finished product.
According to current technique, the Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces of preparation, its granule not only fastens, and granule is less, in reality
Border is difficult to leach during using, and is unfavorable for the Fast Stripping of active ingredient；Medical material only selection, section, big gun special to needs
The medical material of system is inapplicable；For entering whether the coarse powder of clean area meets microbial limit and do not provide processing method.
Summary of the invention
For the deficiencies in the prior art, the present invention provides the preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces, prepared by the method
Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces particle type preferable, degree of tightness appropriateness, be easier to be dried, and granule leach soon, active ingredient dissolution soon,
The microbial limit of products obtained therefrom meets the requirements, and can guarantee that drug safety, with effectively, uses Balanophora dioica R Br ex Royle breaking cellular wall prepared by the method
The time of decoction pieces is short, and process costs is low.
For solving above-mentioned technical problem, the present invention provides following technical scheme: the preparation side of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces
Method, described medical material through picking clean/concoct, be dried, broken, the pulverizer pulverizing of 100 mesh sieves, batch (-type) sterilization, breaking cellular wall, system
Grain, dry prepared Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces.
The preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces, has following steps:
(1) medical material processes: medical material Balanophora dioica R Br ex Royle is through picking cleaning/process of preparing Chinese medicine, medicinal material drying, broken, the pulverizer of 100 mesh sieves
The medicinal material coarse powder of 80～120 mesh is prepared after pulverizing；
(2) batch (-type) sterilization: the medicinal material coarse powder after step (1) being processed carries out sterilizing-and hypopus grow-sterilizes again
Process, until obtaining meeting the medicinal material coarse powder directly taking decoction pieces microbial limit；
(3) breaking cellular wall: the medicinal material coarse powder after sterilization is ground into superfine powder；
(4) soft material processed: the superfine powder that breaking cellular wall prepares is placed in blender, makes soft with the ethanol of water or variable concentrations
Material；
(5) pelletize: soft material is made granule；
(6) Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces will be prepared after particle drying.
Described step (1) Chinese crude drug is dried and refers to that medical material Balanophora dioica R Br ex Royle is dried to water content below 10%；Described step (1)
In broken refer to the medical material Balanophora dioica R Br ex Royle mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh.
What in described step (2), batch (-type) sterilized concretely comprises the following steps: (A) sterilizes: the Balanophora dioica R Br ex Royle medicine after step (1) being processed
Material coarse powder is placed in climatic chamber and keeps drying sterilizing a period of time under uniform temperature；(B) hypopus growth: medical material is thick
Powder temperature in climatic chamber is 20～30 DEG C, relative humidity 70～80% environment in maintain 8～24 hours, then by perseverance
The temperature of constant temperature and humidity case be adjusted to 33～40 DEG C, relative humidity be adjusted to 83～92% maintain 8～24 hours；(C) sterilization again:
Further medicinal material coarse powder is placed in climatic chamber drying sterilizing a period of time at a certain temperature；Conventional sense medical material
Microorganism situation in coarse powder, prepares and meets the medicinal material coarse powder directly taking decoction pieces microbial limit；Described uniform temperature is 50
～80 DEG C；Described a period of time is 0.5～8 hour；The thickness that described medicinal material coarse powder is placed in climatic chamber be 5mm～
30mm。
Further, the concretely comprising the following steps of batch (-type) sterilization in described step (2): (A) sterilizes: in climatic chamber 60
～at 70 DEG C, keep drying sterilizing 0.5～4h；(B) hypopus growth: medicinal material coarse powder temperature in climatic chamber is 20～30
DEG C, relative humidity 70～80% environment in maintain 12～15 hours；Then the temperature of climatic chamber is adjusted to 33～40
DEG C, relative humidity 83～92% environment in maintain 12～15 hours；(C) sterilization again: at climatic chamber 60～70 DEG C
Keep drying sterilizing 0.5～4h.
What in described step (2), batch (-type) sterilized concretely comprises the following steps: (A) sterilizes: the Balanophora dioica R Br ex Royle after step (1) being processed is thick
Powder is placed and is kept drying sterilizing a period of time under uniform temperature in an oven；(B) hypopus growth: by after sterilization processing
Balanophora dioica R Br ex Royle coarse powder takes out from baking oven, pack, when temperature is 20～30 DEG C, be filled with in bag sealing after water vapour maintain 8～
24 hours；(C) sterilization again: the Balanophora dioica R Br ex Royle coarse powder after hypopus grows is placed and is dried the most at a certain temperature
Sterilization a period of time；Microorganism situation in conventional sense Balanophora dioica R Br ex Royle coarse powder, prepares to meet and directly takes decoction pieces microbial limit
Balanophora dioica R Br ex Royle coarse powder；Described uniform temperature is 50～80 DEG C；Described a period of time is 0.5～8 hour；Described Balanophora dioica R Br ex Royle coarse powder is put
Putting the thickness in climatic chamber is 5mm～30mm.
Further, in described step (2) in the concrete steps of batch (-type) sterilization: described a period of time is 0.5～4 little
Time；Described (B) hypopus grows: maintaining growth time is 12～15 hours.
Further, after in described step (2), batch (-type) has sterilized, the microorganism in conventional sense medicinal material coarse powder is not
Meet when directly taking decoction pieces microbial limit, repeat the growth of (B) hypopus and (C) sterilization process 1～4 times；Prepare and meet directly
Connect the medicinal material coarse powder taking decoction pieces microbial limit.
Further, in described step (2), the bag in batch (-type) sterilization is plastic bag or Fibre Bag etc..
Further, described step (2) is filled with water vapour to bag in batch (-type) sterilization, refers to be charged to by sack completely, bag
Son is supported in shape.
Described step (5) is pelletized method particularly includes: the granulator of Balanophora dioica R Br ex Royle soft material 14～24 mesh sieves that will make
Pelletizing, while adding soft material in granulator, add superfine powder, completing until preparing granule；Described granulator be 14～
The oscillating granulator of 24 mesh sieves or squash type granulator.
In the concrete grammar pelletized in described step (5), the ratio of soft material and superfine powder is 3～6:0.5～1.
In described step (6), particle drying is carried out in heated-air circulation oven, design temperature 50～80 DEG C, be dried to
Moisture is less than or equal to 7%.
In described step (6), granule completes after drying, with upper strata 10 mesh, the concussion pelletizing machine granulate screening of bottom 24 mesh sieve
1～3 time, make granule between 10～24 mesh.
Breaking cellular wall in described step (3) method particularly includes: at room temperature and relative humidity in the environment of 30～70%, passes through
The Balanophora dioica R Br ex Royle medicinal material coarse powder of batch (-type) sterilization obtains superfine powder through wall breaking pulverization, and control operating pressure, 0.5～0.8MPa, is divided
Level machine rotating speed is 20～40r/s, more than wall breaking pulverization to 300 mesh；Described room temperature refers to 18～26 DEG C.
In described step (4), blender is trough type mixing machine or wet mixing pelletizer, and the ethanol of described variable concentrations is
The concentration of finger ethanol is 30%～99%.
Further, in the concrete grammar pelletized in described step (5), by step 4) the superfine powder soft material that makes puts into
Oscillating granulator forward direction screen cloth spills a small amount of superfine powder, to reduce the situation of mesh screen blocking.
The screening that the present invention uses the screen cloth clearly pelletized to carry out mesh number makes granularity moderate；Limit is used in pelletization
Adding soft material limit and add the method granulation of breaking cellular wall dry powder, the particle type of gained is preferable, and elasticity is moderate, and the granule prepared is easier to
Being dried, granule leaches comparatively fast.
The sterilization process repeatable operation of medicinal material coarse powder can strengthen sterilization effect, and cycle-index is the first shadow of sterilization process
The factor of sound, circulates the level that substantially can reach to meet the microbial limit directly taking decoction pieces 2 times.Traditional is xeothermic and damp and hot
The high temperature that sterilizing is both needed to more than 80 degrees Celsius processes, and material component exists certain destruction, especially to containing heat
The medical material of quick property composition is inapplicable.The present invention uses the method for batch (-type) sterilizing, the temperature of sterilization process at 50～80 degrees Celsius,
In the environment of keeping being dried, several without destroying to the composition of medical material Balanophora dioica R Br ex Royle, and grow-go out numerous through the brood body-hypopus that goes out
Grow the process of body, in the environment being grown in high humidity of hypopus, after hypopus grows into brood body, kill, kill work
With substantially, the preparation of follow-up Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces, meet the requirement of the microbial limit directly taking decoction pieces.
Beneficial effects of the present invention:
The present invention provides the preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces, by use medical material through picking cleaning/process of preparing Chinese medicine,
Be dried, broken, pulverizer pulverizings of 100 mesh sieves, batch (-type) sterilization, breaking cellular wall, limit add soft material limit add breaking cellular wall dry powder method granulation,
Being dried and prepare Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces, the particle type of the decoction pieces of preparation is preferable, and elasticity is moderate, and the granule prepared is easier to
Being dried, granule leaches comparatively fast, is easily dispersed when user is taken, and batch (-type) sterilization completes within one device so that decoction pieces
Meet the requirement of microbial limit, solve Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces in the market and leach difficult and difficult up to standard the asking of microbial limit
Topic.
By killing the brood body of antibacterial in medicinal material coarse powder at a certain temperature, then under conditions of room temperature high humidity, allow not
Dormancy body grows up to bacterial propagule, then through killing the brood body of the antibacterial in medicinal material coarse powder at a certain temperature, the most repeatedly 0～
4 times, thus the purpose that reaches to sterilize the most thoroughly；Method for disinfection, can not only ensure with the deer being prepared by the method for the present invention
Herba mesonae chinensis breaking cellular wall decoction pieces meets the microbial limit requirement directly taking decoction pieces, and is able to ensure that the medication of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces
Safety and drug effect.The sterilising temp of the medicinal material coarse powder of preparation is 50～80 degrees Celsius, several without impact on the content of medical material Balanophora dioica R Br ex Royle,
So that it is guaranteed that drug effect and sterilizing；Do not have the situation of the oxidized degeneration of effective ingredient of medical material Balanophora dioica R Br ex Royle；The time of method is short,
Consume energy low.It addition, the present invention uses climatic chamber, it is effectively guaranteed the growing environment of hypopus in medicinal material coarse powder, simultaneously
Can effectively prevent that the situation that foreign body, dust enter medicinal material coarse powder occurs owing to medicinal material coarse powder moves when batch (-type) sterilizing,
Effectively prevent secondary pollution, it can be ensured that the drug safety of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces and drug effect.It addition, the present invention uses to bag
In be filled with water vapour, be effectively guaranteed the humidity of the growing environment of hypopus in medicinal material coarse powder, pack can be the most anti-simultaneously
Only in hypopus growth course, occur that foreign body, dust enter the situation of medicinal material coarse powder due to medicinal material coarse powder, effectively prevent two
Secondary pollution, it can be ensured that the drug safety of breaking cellular wall decoction pieces and drug effect.By using limit to add the method system that soft material limit adds breaking cellular wall dry powder
Grain, the particle type of gained is preferable, and elasticity is moderate, and the granule prepared is easier to be dried, and granule leaches comparatively fast.The present invention carries
The method of confession adds Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces dry powder in pelletization, and prepared granule elasticity is moderate, the later stage is dried,
Granulate is strong, is easily dispersed when user is taken, and solves Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces in the market and leaches difficult and microorganism limit
The difficult problem up to standard of degree.
The preparation method that the present invention provides is simple, easily operates, low cost, is suitable for commercial Application.
Detailed description of the invention
With specific embodiment, the present invention is further illustrated below, but the present invention is not limited by following embodiment.
Embodiment 1
Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces
1) medical material process: by Balanophora dioica R Br ex Royle medical material through pick cleaning/process of preparing Chinese medicine, medicinal material drying to medical material water content 10% with
Under, the medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh；Coarse pulverization medical material reaches further
About 100 mesh；
2) batch (-type) sterilization: Balanophora dioica R Br ex Royle coarse powder is put in climatic chamber, places thickness and is about 10mm, and arranging temperature is 65
DEG C (actual temperature is 60～70 DEG C), keeps drying sterilizing 8h；Medicinal material coarse powder after process is 25 DEG C, relative humidity in temperature
75% maintains 12 hours；Then the temperature of climatic chamber is adjusted to 35 DEG C, relative humidity 88% maintain 24 hours；Change sets
Putting temperature is 75 DEG C (actual temperature is 70～80 DEG C), keeps drying sterilizing 4h；Microorganism feelings in conventional sense medicinal material coarse powder
Condition, must meet the Balanophora dioica R Br ex Royle coarse powder directly taking decoction pieces microbial limit requirement；
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100～120 mesh at room temperature and relative humidity in the environment of 30%, warp
Wall breaking pulverization, controls operating pressure and more than 20r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.6MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns)；
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 50～60% ethanol, makes
Soft material；
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 16 mesh, and during granulation, limit adds step 4) the wall cell disruption powder soft material that makes time limit add step 3) prepare
Balanophora dioica R Br ex Royle superfine powder, soft material is 3:1 with the ratio of superfine powder；
6) it is placed in 70 DEG C～80 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 2 times, and subpackage i.e. obtains Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces.
Embodiment 2
Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces
1) medical material processes: by Balanophora dioica R Br ex Royle medical material through picking the water content cleaned/concoct, be dried to medical material below 10%,
The medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh；Coarse pulverization medical material reaches 100 further
About mesh；
2) batch (-type) sterilization: Balanophora dioica R Br ex Royle coarse powder is put in climatic chamber, places thickness and is about 5mm, and arranging temperature is 70
DEG C (actual temperature is 65～75 DEG C), keeps drying sterilizing 4h；Medicinal material coarse powder after process is 20 DEG C, relative humidity in temperature
70% maintains 15 hours；Then the temperature of climatic chamber is adjusted to 33 DEG C, relative humidity 83% maintain 8 hours；Change sets
Putting temperature is 65 DEG C (actual temperature is 60～70 DEG C), keeps drying sterilizing 6h；Repeat hypopus grow-again to go out bacterial reproduction
Body step 1 time, the microorganism situation in conventional sense medicinal material coarse powder；The deer directly taking decoction pieces microbial limit requirement must be met
Herba mesonae chinensis coarse powder；
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100～120 mesh at room temperature and relative humidity in the environment of 50%, warp
Wall breaking pulverization, controls operating pressure and more than 40r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.5MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns)；
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 30～40% ethanol, makes
Soft material；
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 20 mesh, and during granulation, limit adds step 4) the superfine powder soft material that makes time limit add step 3) prepare
Balanophora dioica R Br ex Royle superfine powder, the ratio of soft material and superfine powder is 3:0.5；
6) it is placed in 60 DEG C～70 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 1 time, and subpackage i.e. obtains Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces.
Embodiment 3
Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces
1) medical material processes: by Balanophora dioica R Br ex Royle medical material through picking the water content cleaned/concoct, be dried to medical material below 10%,
The medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh；Coarse pulverization medical material reaches 100 further
About mesh；
2) batch (-type) sterilization: Balanophora dioica R Br ex Royle coarse powder is put in climatic chamber, places thickness and is about 30mm, and arranging temperature is 75
DEG C (actual temperature is 70～80 DEG C), keeps drying sterilizing 4h；Medicinal material coarse powder after process is 25 DEG C, relative humidity in temperature
75% maintains 24 hours；Then the temperature of climatic chamber is adjusted to 40 DEG C, relative humidity 80% maintain 12 hours；By medical material
Coarse powder is in climatic chamber, and placement thickness is 10mm, and arranging temperature is 80 DEG C (actual temperature is 75～85 DEG C), keeps being dried
Sterilization 0.5h；Repeat step 4 time, the microorganism situation in conventional sense medicinal material coarse powder；Must meet and directly take decoction pieces microorganism
The Balanophora dioica R Br ex Royle coarse powder of bound requirements；
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100～120 mesh at room temperature and relative humidity in the environment of 70%, warp
Wall breaking pulverization, controls operating pressure and more than 30r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.8MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns)；
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 60～70% ethanol, makes
Soft material；
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 20 mesh, and during granulation, limit adds step 4) the superfine powder soft material that makes time limit add step 3) prepare
Balanophora dioica R Br ex Royle superfine powder, the ratio of soft material and superfine powder is 6:1；
6) it is placed in 50 DEG C～60 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 3 times, and subpackage i.e. obtains Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces.
Embodiment 4
Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces
1) medical material processes: by Balanophora dioica R Br ex Royle medical material through picking the water content cleaned/concoct, be dried to medical material below 10%,
The medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh；Coarse pulverization medical material reaches 100 further
About mesh；
2) batch (-type) sterilization: Balanophora dioica R Br ex Royle coarse powder is put in climatic chamber, often dish placement thickness is about 25mm, arranges temperature
It is 55 DEG C (actual temperature is 50～60 DEG C), keeps drying sterilizing 0.5h；Be adjusted to 30 DEG C, relative humidity 80% maintains
8 hours, be adjusted to 37 DEG C, relative humidity 92% maintain 15 hours；Medicinal material coarse powder is put in climatic chamber, often dish
Placement thickness is 5mm, and arranging temperature is 55 DEG C (actual temperature is 50～60 DEG C), keeps drying sterilizing 8h；Conventional sense medical material
Microorganism situation in coarse powder, is repeated 2 times again, the microorganism situation in conventional sense medicinal material coarse powder；Must meet and directly take
The Balanophora dioica R Br ex Royle coarse powder that decoction pieces microbial limit requires；
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100～120 mesh at room temperature and relative humidity in the environment of 40%, warp
Wall breaking pulverization, controls operating pressure and more than 30r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.7MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns)；
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 80～99% ethanol, makes
Soft material；
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 20 mesh, and during granulation, limit adds step 4) the wall cell disruption powder soft material that makes time limit add step 3) prepare
Balanophora dioica R Br ex Royle superfine powder, soft material is 6:0.5 with the ratio of superfine powder；
6) it is placed in 50 DEG C～60 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 3 times, and subpackage i.e. obtains Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces.
Embodiment 5
Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces
1) medical material process: by Balanophora dioica R Br ex Royle medical material through pick cleaning/process of preparing Chinese medicine, medicinal material drying to medical material water content 10% with
Under, the medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh；Coarse pulverization medical material reaches further
About 100 mesh；
2) batch (-type) sterilization: go out bacterial propagule: Balanophora dioica R Br ex Royle coarse powder is put in baking oven, places thickness and is about 5mm, arrange temperature
Degree is 70 DEG C (actual temperature is 65～75 DEG C), keeps drying sterilizing 4h；Hypopus grows: the medicinal material coarse powder after process is from baking oven
Middle taking-up, pack, when temperature is 20 DEG C, after being filled with water vapour in bag, sealing maintains 15 hours；Go out bacterial propagule again:
Medicinal material coarse powder being put in baking oven, placement thickness is 20mm, and arranging temperature is 65 DEG C (actual temperature is 60～70 DEG C), keeps dry
Dry sterilization 6h；Repeat hypopus grow-again to go out bacterial propagule step 1 time, the microorganism feelings in conventional sense medicinal material coarse powder
Condition；The Balanophora dioica R Br ex Royle coarse powder directly taking decoction pieces microbial limit requirement must be met；
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100～120 mesh at room temperature and relative humidity in the environment of 30%, warp
Wall breaking pulverization, controls operating pressure and more than 20r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.6MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns)；
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 50～60% ethanol, makes
Soft material；
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 16 mesh, and during granulation, limit adds step 4) the superfine powder soft material that makes time limit add step 3) prepare
Balanophora dioica R Br ex Royle superfine powder, the ratio of soft material and superfine powder is 4:1；
6) it is placed in 70 DEG C～80 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 2 times, and subpackage i.e. obtains Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces.
Embodiment 6
Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces
1) medical material processes: by Balanophora dioica R Br ex Royle medical material through picking the water content cleaned/concoct, be dried to medical material below 10%,
The medical material mechanical crusher of the screen cloth of 10 mesh is broken into the little granule about 10 mesh；Coarse pulverization medical material reaches 100 further
About mesh；
2) batch (-type) sterilization: go out bacterial propagule: Balanophora dioica R Br ex Royle coarse powder is placed in an oven, places thickness and is about 10mm, if
Putting temperature is 65 DEG C (actual temperature is 60～70 DEG C), keeps drying sterilizing 8h；Hypopus grow: the medicinal material coarse powder after process from
Taking out in baking oven, pack, when temperature is 25 DEG C, after being filled with water vapour in bag, sealing maintains 12 hours；Go out bacterial propagule:
Medicinal material coarse powder being put in baking oven, placement thickness is 30mm, and arranging temperature is 75 DEG C (actual temperature is 70～80 DEG C), keeps dry
Dry sterilization 4h；Microorganism situation in conventional sense medicinal material coarse powder, must meet the deer directly taking decoction pieces microbial limit requirement
Herba mesonae chinensis coarse powder；
3) breaking cellular wall: by particle diameter the medicinal material coarse powder of 100～120 mesh at room temperature and relative humidity in the environment of 50%, warp
Wall breaking pulverization, controls operating pressure and more than 40r/s, wall breaking pulverization to 300 mesh, obtains ultra-fine at 0.5MPa, grader rotating speed
Powder body (90% powder size is less than 45 microns)；
4) soft material processed: be placed in trough type mixing machine by prepared superfine powder, adds appropriate 30～40% ethanol, makes
Soft material；
5) pelletize: by step 4) the superfine powder soft material that makes put into oscillating granulator forward direction screen cloth spills the most ultra-fine
Powder body, pelletizes with the screen cloth of 20 mesh, and during granulation, limit adds step 4) the superfine powder soft material that makes time limit add step 3) prepare
Balanophora dioica R Br ex Royle superfine powder, the ratio of soft material and superfine powder is 5:0.5；
6) it is placed in 60 DEG C～70 DEG C of baking ovens is dried taking qualified breaking cellular wall decoction pieces granule, dried granule upper strata 10
Mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 1 time, and subpackage i.e. obtains Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces.
Leach time detecting test
Test method: take about 2g prepare dry granule be placed in the transparent cup of 300 milliliters, add 90 degrees Celsius Celsius to 95
100 milliliters of the water (being no longer heat up during shaking) of degree, shakes 1 minute, 2 minutes, 3 points with the clockwise direction of 1 circle per second
Clock, 5 minutes, see granule in cup after 10 minutes leach situation, separately take the American-European gram LS-609 laser grain of liquid 0.5 milliliter in cup
Degree instrument detection shading rate, result of the test see table 1:
Knowable to table 1 data, the superfine powder method of granulating that the present invention provides is more preferable than the effect of conventional method of granulating, molten
Go out diffusion rate than conventional method faster.
Microbial limit detection test
By " Chinese Pharmacopoeia " 2015 editions the 4th the 140-151 page
1105 non-sterile product microbial limit detections: microorganism count method
1106 non-sterile product microbial limit detections: Control bacteria examination method
1107 non-sterile medicine limitation standard in microbes
According to the method for pharmacopeia, the sample of embodiment 1～6 is carried out microbial limit detection to test, concrete outcome such as table 2:
The detection test of table 2 microbial limit
Knowable to table 2 data, batch (-type) sterilizing methods is more preferable than conventional dry heat sterilization effect, more can guarantee that hygiology matter
Amount.
The foregoing is only the preferred embodiments of the present invention, be not limited to the present invention, for the skill of this area
For art personnel, the present invention can have various modifications and variations.All within the spirit and principles in the present invention, that is made any repaiies
Change, equivalent, improvement etc., should be included within the scope of the present invention.
Claims (10)
1. the preparation method of a Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces, it is characterised in that there are following steps:
(1) medical material processes: Balanophora dioica R Br ex Royle is system after picking the pulverizer pulverizing of cleanings/processs of preparing Chinese medicine, medicinal material drying, broken, 100 mesh sieves
Obtain the Balanophora dioica R Br ex Royle coarse powder of 80～120 mesh；
(2) batch (-type) sterilization: the Balanophora dioica R Br ex Royle coarse powder after step (1) being processed carries out sterilizing-mistake that grow-again sterilizes of hypopus
Journey, until obtaining meeting the Balanophora dioica R Br ex Royle coarse powder directly taking decoction pieces microbial limit；
(3) breaking cellular wall: the Balanophora dioica R Br ex Royle coarse powder after sterilization is ground into Balanophora dioica R Br ex Royle superfine powder；
(4) soft material processed: the Balanophora dioica R Br ex Royle superfine powder that breaking cellular wall prepares is placed in blender, makes with the ethanol of water or variable concentrations
Soft material；
(5) pelletize: soft material is made Balanophora dioica R Br ex Royle granule；
(6) Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces will be prepared after particle drying.
The preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces the most according to claim 1, it is characterised in that described step (2)
Concretely comprising the following steps of middle batch (-type) sterilization: (A) sterilizes: it is permanent that the Balanophora dioica R Br ex Royle medicinal material coarse powder after step (1) being processed is placed on constant temperature
Wet tank keeps drying sterilizing a period of time under uniform temperature；(B) hypopus growth: by medicinal material coarse powder in the middle temperature of climatic chamber
Degree is 20～30 DEG C, relative humidity 70～80% environment in maintain 8～24 hours, then the temperature of climatic chamber is adjusted
Be 33～40 DEG C, relative humidity is adjusted to 83～92% and maintains 8～24 hours；(C) sterilization again: further by medicinal material coarse powder
It is placed in climatic chamber drying sterilizing a period of time at a certain temperature；Microorganism feelings in conventional sense medicinal material coarse powder
Condition, prepares and meets the medicinal material coarse powder directly taking decoction pieces microbial limit；Described uniform temperature is 50～80 DEG C；When described one section
Between be 0.5～8 hour；The thickness that described medicinal material coarse powder is placed in climatic chamber is 5mm～30mm.
The preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces the most according to claim 1, it is characterised in that described step (2)
Concretely comprising the following steps of middle batch (-type) sterilization: (A) sterilizes: the Balanophora dioica R Br ex Royle coarse powder after step (1) being processed is placed the most certain
At a temperature of keep drying sterilizing a period of time；(B) hypopus growth: by the Balanophora dioica R Br ex Royle coarse powder after sterilization processing from baking oven
Taking out, pack, when temperature is 20～30 DEG C, after being filled with water vapour in bag, sealing maintains 8～24 hours；(C) sterilization again:
Balanophora dioica R Br ex Royle coarse powder after hypopus grows is placed drying sterilizing a period of time the most at a certain temperature；Conventional inspection
Survey the microorganism situation in Balanophora dioica R Br ex Royle coarse powder, prepare and meet the Balanophora dioica R Br ex Royle coarse powder directly taking decoction pieces microbial limit；Described one
Fixed temperature is 50～80 DEG C；Described a period of time is 0.5～8 hour；Described Balanophora dioica R Br ex Royle coarse powder is placed in climatic chamber
Thickness is 5mm～30mm.
The preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces the most according to claims 2 to 3, it is characterised in that described step
(2), after in, batch (-type) has sterilized, the microorganism in conventional sense medicinal material coarse powder does not meets directly takes decoction pieces microbial limit
Time, repetition (B) hypopus growth and (C) sterilization process 1～4 times；Prepare and meet the medical material directly taking decoction pieces microbial limit
Coarse powder.
The preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces the most according to claims 1 to 3, it is characterised in that described step
(5) pelletize in method particularly includes: the soft material the made granulator of 14～24 mesh sieves is pelletized, is adding in granulator
Adding Balanophora dioica R Br ex Royle superfine powder while soft material, completing until preparing granule；Described granulator is the swing system of 14～24 mesh sieves
Grain machine or squash type granulator.
The preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces the most according to claim 5, it is characterised in that described step (5)
In the concrete grammar of middle granulation, the ratio of soft material and Balanophora dioica R Br ex Royle superfine powder is 3～6:0.5～1.
The preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces the most according to claims 1 to 3, it is characterised in that described step
(1) Chinese crude drug is dried and refers to that Balanophora dioica R Br ex Royle is dried to water content below 10%；In described step (1), Balanophora dioica R Br ex Royle is used by broken referring to
The mechanical crusher of the screen cloth of 10 mesh is broken into the little granule of the Balanophora dioica R Br ex Royle about 10 mesh.
The preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces the most according to claims 1 to 3, it is characterised in that described step
(6) in, particle drying is carried out in heated-air circulation oven, design temperature 50～80 DEG C, is dried to moisture less than or equal to 7%；
In described step (6), granule completes after drying, and with upper strata 10 mesh, the concussion pelletizing machine granulate of bottom 24 mesh sieve sieves 1～3 time,
Make granule between 10～24 mesh.
The preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces the most according to claims 1 to 3, it is characterised in that described broken step
Suddenly breaking cellular wall in (3) method particularly includes: at room temperature and relative humidity in the environment of 30～70%, through step (2) batch (-type)
The Balanophora dioica R Br ex Royle coarse powder of sterilization obtains Balanophora dioica R Br ex Royle superfine powder through wall breaking pulverization, controls operating pressure 0.5～0.8MPa, grader
Rotating speed is 20～40r/s, more than wall breaking pulverization to 300 mesh；Described room temperature refers to 18～26 DEG C.
The preparation method of a kind of Balanophora dioica R Br ex Royle breaking cellular wall decoction pieces the most according to claim 9, it is characterised in that described step (4)
Middle blender is trough type mixing machine or wet mixing pelletizer, the ethanol of described variable concentrations refer to the concentration of ethanol be 30%～
99%.
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| CN114594222A (en) * | 2022-03-29 | 2022-06-07 | 四川浦华中药科技有限公司 | Decoction piece detection method based on traditional Chinese medicine formula granules |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103316054A (en) * | 2013-06-01 | 2013-09-25 | 普洱淞茂制药股份有限公司 | Balanophora involucrata superfine pure powder, preparation method therefor and preparations thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103316054A (en) * | 2013-06-01 | 2013-09-25 | 普洱淞茂制药股份有限公司 | Balanophora involucrata superfine pure powder, preparation method therefor and preparations thereof |
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| 张萍萍: "中药灭菌新方法", 《化学工程与装备》 * |
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|---|---|---|---|---|
| CN114594222A (en) * | 2022-03-29 | 2022-06-07 | 四川浦华中药科技有限公司 | Decoction piece detection method based on traditional Chinese medicine formula granules |
| CN114594222B (en) * | 2022-03-29 | 2023-06-23 | 四川浦华中药科技有限公司 | Decoction piece detection method based on traditional Chinese medicine formula particles |
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